Trial Outcomes & Findings for Imaging the Neurobiology of a Behavioral Treatment for Cocaine Dependence (NCT NCT00376558)

Results Overview

The relationship between Methylphenidate-induced Dopamine Release in the Striatum (Measured by Displacement of \[11C\]-Raclopride by Oral Methylphenidate) and Treatment Response (Measured Using Community Reinforcement Approach and Contingency Management) was studied. Dopamine Function was assessed by evaluation of endogenous Dopamine release over the course of treatment (i.e., at 3 months as compared to baseline). Endogenous Dopamine release is inversely related to the change in binding potential (delta BPND) of \[11C\]raclopride, in that a negative delta BPND, or increased displacement of \[11C\]raclopride, reflects an increase in the release of endogenous dopamine over the course of treatment.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

baseline and 3 months

Results posted on

2016-07-01

Participant Flow

Participant milestones

Participant milestones
Measure	Cocaine Users Cocaine users receiving CRA	Control Subjects Healthy controls who undergo scans
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Imaging the Neurobiology of a Behavioral Treatment for Cocaine Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cocaine Users n=25 Participants Cocaine users receiving CRA	Control Subjects n=25 Participants Healthy controls who undergo scans	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=99 Participants	25 Participants n=107 Participants	50 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	37 years STANDARD_DEVIATION 7 • n=99 Participants	38 years STANDARD_DEVIATION 6 • n=107 Participants	37 years STANDARD_DEVIATION 7 • n=206 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants
Sex: Female, Male Male	22 Participants n=99 Participants	22 Participants n=107 Participants	44 Participants n=206 Participants
Region of Enrollment United States	25 participants n=99 Participants	25 participants n=107 Participants	50 participants n=206 Participants

PRIMARY outcome

Timeframe: baseline and 3 months

Population: Analysis for change in binding potential (binding potential difference; at baseline versus stimulant induced binding potential) was done with 24 cocaine users since one of the subjects only underwent baseline scanning. However, treatment data for all 25 cocaine users was used.

The relationship between Methylphenidate-induced Dopamine Release in the Striatum (Measured by Displacement of \[11C\]-Raclopride by Oral Methylphenidate) and Treatment Response (Measured Using Community Reinforcement Approach and Contingency Management) was studied. Dopamine Function was assessed by evaluation of endogenous Dopamine release over the course of treatment (i.e., at 3 months as compared to baseline). Endogenous Dopamine release is inversely related to the change in binding potential (delta BPND) of \[11C\]raclopride, in that a negative delta BPND, or increased displacement of \[11C\]raclopride, reflects an increase in the release of endogenous dopamine over the course of treatment.

Outcome measures

Outcome measures
Measure	Cocaine Users n=24 Participants Cocaine users receiving CRA	Control Subjects n=25 Participants Healthy controls who undergo scans
Change From Baseline in the Binding Potential of [11C]Raclopride	-13.7 ratio Standard Deviation 8.7	-5.8 ratio Standard Deviation 8.6

SECONDARY outcome

Timeframe: 2x/week for 24 weeks

Population: The number of subjects was determined from previous studies using CM/CRA

measurement of abstinence, measured as vouchers earned and clinical appointments attended using CRA

Outcome measures

Outcome measures
Measure	Cocaine Users n=25 Participants Cocaine users receiving CRA	Control Subjects Healthy controls who undergo scans
Cocaine Craving, Withdrawal Symptoms, Pattern of Cocaine Use	650 dollars Standard Deviation 0.2	—

Adverse Events

Cocaine Users

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Diana Martinez

nyspi

Phone: 212-543-6628

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place